The Efficacy of Darolutamide for Non Metastatic Castration-Resistant Prostate Patients

Neal Shore | January 20, 2020

In July 2019, darolutamide became the newest available oral androgen receptor inhibitor approved by the FDA for the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC) patients. The Phase 3 ARAMIS trial evaluated darolutamide with androgen deprivation therapy (ADT) versus ADT plus placebo for nmCRPC patients and demonstrated significant improvement in metastasis-free survival (MFS), extending MFS to 40 months for those treated with darolutamide as opposed to 18 months for patients randomized to the ADT + placebo arm.


Neal Shore, MD, FACS

Neal Shore, MD, is the Medical Director of the Carolina Urologic Research Center. He practices with Atlantic Urology Clinics in Myrtle Beach, South Carolina. He serves on several industry advisory boards as well as academic and advocacy networks: including the Society Urologic Oncology Clinical Trials Consortium, Bladder Cancer Advocacy Network, and the Large Urology Group Practice Association. Dr. Shore is the editor-in-chief of UroToday’s print publication, Everyday Urology- Oncology Insights.

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Written by Zachary Klaassen, MD
April 16, 2019
Since Drs. Huggins and Hodges demonstrated the androgen dependent nature of prostate cancer in the 1940’s, androgen deprivation therapy (ADT) has been the mainstay treatment (albeit not curative) of advanced disease.
Conference Coverage
Recent data from conferences worldwide
Presented by Boris Hadaschik, MD
Athens, Greece ( Dr. Boris Hadaschik presented on the disease entity of non-metastatic castrate-resistant prostate cancer (nmCRPC).
Presented by Matthew R. Smith, MD, PhD
Barcelona, Spain ( The randomized, phase 3 SPARTAN trial showed that apalutamide offered a metastasis-free survival (MFS) benefit over placebo for patients with non-metastatic
Presented by Christopher Parker, MD
Barcelona, Spain ( The optimal timing of radiotherapy after radical prostatectomy for prostate cancer is uncertain. Supporters of adjuvant radiotherapy suggest that earlier treatment may be more effective,
Presented by Matthew R. Smith, MD, PhD
Barcelona, Spain ( In the phase III placebo-controlled SPARTAN study, apalutamide with ongoing androgen deprivation therapy (ADT) significantly improved metastasis-free survival (MFS) (HR 0.28, 95% CI, 0.23-0.35),
Presented by Teuvo Tammela, MD, PhD
Barcelona, Spain (  Dr. Teuvo Tammela presented results of the recently published ARAMIS trial. Non-metastatic (M0) CRPC (nmCRPC) is defined as a rising PSA in the setting of non-metastatic disease in the castrate state.
Presented by Karim Fizazi, MD, PhD
San Francisco, CA ( The use of androgen-axis targeted agents, specifically enzalutamide and abiraterone, have drastically changed the landscape of advanced prostate cancer management. Just last year, at GU ASCO 2018,
Presented by Neil Fleshner, MD, MPH, FRCSC
Toronto, Ontario ( Dr. Neil Fleshner presented the question in debate of whether we should be treating non-metastatic castrate-resistant prostate cancer (nmCRPC) patients or wait until they have developed metastases.
Presented by Maha Hussain, MD, FACP, FASCO
San Francisco, CA ( Dr. Maha Hussain provided the first presentation of the phase III randomized double-blind controlled trial, the following men were eligible for inclusion